UNIT 11 INVESTIGATE WESTERN HERBAL PRODUCTS
HISTORY OF TRADITIONAL WESTERN HERBAL MEDICINE The father of Western medicine, Hippocrates (460 BC - 377 BC) is known to have used many plants and herbs for medicinal purposes. Hippocrates' use of up to 400 plants are well documented in a collection called the Corpus Hippocraticum. Western herbal medicines have traditionally been used to help prevent and treat diseases. Many useful pharmaceuticals have been derived from such herbs, including: salicylic acid to make aspirin from the bark of the white willow tree (Salix alba); morphine from the poppy plant (Papaver somniferum); digitalin, digitoxin and digoxin from the plant foxglove (Digitalis purpurea); atropine from the belladonna plant (Atropa belladonna) and; quinine from the bark of the quinine tree (Cinchona ledgeriana)
Western herbal medicine (WHM) Western Herbal Medicine (WHM) is a clinical practice of healing using naturally occurring plant material or plants with little or no industrial processing. Medicines or extracts from crude plant material, such as root, bark, and flower, are used in multiple plant formulations to treat persons with disease and dysfunction and to promote health and well-being WHM is also referred to as traditional Western herbalism, herbal or botanical medicine, medical herbalism and phytotherapy. WHM is practised in Australia, Canada, New Zealand, the United Kingdom, the United States and Western Europe.
Traditional knowledge of WHM is evident in the use of individually tailored crude plant extracts in multiple plant formulations. Treatments directed at the cause of the problem, focusing holistically on the whole person with the intent to strengthen the overall constitution, shift causal and global patterns of dysfunction and imbalance Western herbal medicine involves using plants and plant material to create medicines to help prevent or treat various illnesses. These materials may use some or all parts of a plant, such as flowers, roots, fruits, leaves, and bark.
SAFETY, EFFICACY AND QUALITY ON HERBAL PRODUCTS WHO GUIDELINES Safety, effectiveness and quality tests to herbal medicines are limited due to their complex nature, authentication issues and lack of appropriate standardization. The safety, effectiveness and quality of finished herbal medicine products depend on the quality of their source materials, which can include hundreds of natural constituents, and how elements are processed while manufacturing them. Countries have their own set of laws and regulations for herbal medicines and traditional medicines. W H O recommends that each country or area should adopt a regulatory system to manage the appropriate use of herbal medicines. Adopting a regulatory mechanism has always helped in ensuring that herbal medicines have acceptable quality, safety and efficacy.
The WHO Guidelines for the assessment of herbal medicines may be consulted when assessment processes for herbal medicines are being prepared The W H O guidelines on good agricultural and collection practices for medicinal plants are intended for national regulatory bodies and offer advice on cultivation and collection methods, site selection, climate and soil considerations and the correct identification of seeds and plants These guidelines also offer guidance on post-harvest operations such as labelling and legal components including national and regional laws on quality standards, patent status and benefits sharing Protocols on safety, efficacy, standardization and documentation of herbal medicines have also been published by IUPAC subcommittee on biomolecular chemistry
European Regulations and Guidelines Herbal medicinal products fall within the scope of the European Directive 2001/83/EC that foresees marketing of each medicinal product and requires an ad-hoc authorisation to be granted on the basis of results of tests and experimentations concerning quality, safety and efficacy. The main features of Directive 2001/EC are traditional herbal medicine definition, simplified registration procedure, provisions for community herbal monographs and community list of herbal substances and preparations and establishment of the Committee for Herbal Medicinal Products (HMPC). Committee for Herbal Medicinal Products (HMPC), Committee of European Medicines Agency (EMA) is developing guidelines for quality, nonclinical studies, clinical efficacy and safety European Directive 2004/24/EC on traditional herbal medicinal products has brought forward specifically in recognition of the position that for many herbal medicines it was difficult for companies to meet the full requirements for a marketing authorisation, particularly in relation to efficacy, as are required under Directive 2001/83/EC
Committee for Herbal Medicinal Products (HMPC) HMPC is the agency responsible for the evaluation of medicinal products and to carry out tasks concerning the simplified registration and authorization of herbal medicinal products. HMPC establish Community herbal monographs and list herbal substances and preparations. Monographs in European Pharmacopoeia provide the quality requirements for herbal substances and preparations. HMPC has also addressed general quality matters in several guidance documents concerning to non-clinical, quality, clinical efficacy and safety issues. The HMPC is responsible for identifying the priority herbal substances/preparations/combinations to be covered by a monograph or a list entry.
Medicines and Healthcare products Regulatory Agency (MHRA) for UK Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development The agency has 3 centres: the Clinical Practice Research Datalink (CPRD), a data research service that aims to improve public health by using anonymised NHS clinical data the National Institute for Biological Standards and Control (NIBSC), a global leader in the standardisation and control of biological medicines the Medicines and Healthcare products Regulatory Agency (MHRA), the UK s regulator of medicines, medical devices and blood components for transfusion, responsible for ensuring their safety, quality and effectiveness Traditional herbal medicines registration scheme (THMRS) has been recently introduced by Medicines and Healthcare Products Regulatory Agency (MHRA, UK).
United States of America Regulations In United States, the term complementary/alternative medicines (CAM) are most commonly used for traditional medicine systems. "Complementary medicine" refers to use of CAM together with conventional medicine, such as using acupuncture, in addition to usual care to help lessen pain. Most use of CAM by Americans is complementary (National Center for Complementary and Alternative Medicine (http://nccam.nih.gov). Alternative medicine refers to use of CAM in place of conventional medicine. "Integrative medicine" (also called integrated medicine) refers to a practice that combines both conventional and CAM treatments for which there is evidence of safety and effectiveness
FDA in its draft guidance Guidance for industry on complementary and alternative medicine products and regulation by the food and their regulation by the food and drug administration clarified different categories of Complimentary Alternative Medicines (CAM) products into cosmetic; device; dietary supplement; drug, as well as "new drug" and "new animal drug;" food; and food additive. FDA guidelines on botanical drug products established New Drug Application (NDA) route parallel closely the route followed for a synthetic new chemical entity
HERBS AS DIETARY SUPPLEMENTS IN USA The Dietary Supplement Health and Education Act (DSHEA) of 1994 classifies herbs as dietary supplements. This law defines supplements quite broadly as anything that supplements the diet. Supplements therefore include vitamins, minerals, herbs, amino acids, enzymes, organ tissues, metabolites, extracts, or concentrates. A major difference between a drug and a dietary supplement is that dietary supplements may not claim to diagnose, cure, mitigate, treat, or prevent illness It is interesting to note that dietary supplement manufacturers are allowed to make certain structure/function claims, which are often vaguely worded claims of health benefits. For example, an Echinacea product (often used to treat or prevent the common cold) might claim to support the body s natural defenses. Dietary supplements can be produced, sold, and marketed without first demonstrating safety and efficacy, as is required for pharmaceutical drugs.
EXAMPLES OF WESTERN HERBS St. John's Wort Black Cohosh Feverfew
EXAMPLES OF WESTERN HERBS evening primrose flower Boswellia White Willow Bark
Examples of Western Herbal Products Ingredients: Oregon Grape Root (Berberis aquafolium), Grain Alcohol, Deionized Water Serving Size: 333 mg/ml (30 drops) Dosage: General (long-term) 10-40 drops, 2-3 times per day or as needed in juice or water. Properties: Bitter Tonic, Anti-bacterial Overview: Oregon Grape can be used acutely in larger doses or long term in smaller doses as a tonic. Complimentary Formulas: Liver-Detox Caution: Not recommended if pregnant References: Healthnotes Monographs, Healthnotes, Inc. 2006.
Ingredients: Fresh St. John's Wort, Grain Alcohol, Deionized Water Amount Per Serving: 450 mg per 1 veggie capsule Serving Size: 1 capsule: 1-3 times daily Properties: Anti-Depressent, Sedative, Vulnerary (heals tissue) Indications: Clinical guidelines from the American College of Physicians-American Society of Internal Medicine suggest that St. John's wort can be considered an option along with conventional antidepressants for short-term treatment of mild depression (1). However, since St. John's wort has not been shown to be more effective and since St. John's wort causes many drug interactions, it might not be an appropriate choice for many patients, particularly those who take other conventional drugs. Adverse Effects: Orally, St. John's wort is usually well tolerated (2). Side effects can include insomnia, vivid dreams, restlessness, anxiety, agitation, irritability, gastrointestinal (GI) discomfort, diarrhea, fatigue, dry mouth, dizziness, and headache. Insomnia can often be alleviated by decreasing the dose or taking St. John's wort in the morning Caution: Not recommended if nursing or pregnatn. St. John's wort has been associated with potentially serious interactions with certain drugs. May potentiate MAO-inhibitors. Check with your doctor to see if St. John's Wort is appropriate if you are on medications or are severely depressed.
GROUP ACTIVITY!! FORM GROUP OF TWO MEMBERS (Total group would be 5) Choose one western herbs. Search information for western herbs with the intended used and effective dosage Search the information on evaluation method for quality, safety and efficacy of selected herbs.